Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

NCT ID: NCT06686862

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2027-05-31

Brief Summary

Prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of a 3-week ibuprofen tapering regimen compared to conventional analgesic treatment (acetaminophen) in patients with acute myocarditis and left ventricular ejection fraction ≥50%. The objective is to assess the reduction in late gadolinium enhancement on cardiac magnetic resonance imaging at 6-month follow-up.

Detailed Description

The treatment for patients with uncomplicated myocarditis (left ventricular ejection fraction >50% without heart failure) is not currently well defined. Analgesic drugs are commonly used to manage pain. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) among analgesics is controversial due to potential harmful effects observed in animal models. However, NSAIDs are the standard treatment for pericarditis, even when it is associated with mild myocardial involvement. In patients with acute myocarditis and normal left ventricular ejection fraction, observational studies have suggested that NSAIDs may have a beneficial effect in reducing late gadolinium enhancement (LGE) measured in cardiac magnetic resonance (CMR), an important prognostic marker in this population.

We plan to conduct a prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of NSAIDs versus conventional analgesic treatment in patients with uncomplicated acute myocarditis and left ventricular ejection fraction ≥50%.

Approximately 150 patients will be randomized 1:1 to NSAID treatment (ibuprofen tapering schedule during 3 weeks) or conventional treatment (acetaminophen or metamizole in case of allergy until pain resolution) during hospital admission. Patients will be followed for a 12-month period. Baseline CMR will be performed at initial hospitalization for acute myocarditis and at 3 and 6 months.

The primary objective is to assess the utility of ibuprofen versus conventional treatment with analgesics in acute myocarditis with preserved LVEF, in terms of reducing LGE on CMR at 6-month follow-up compared to baseline.

Conditions

Myocarditis Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ibuprofen

Ibuprofen tapering schedule during 3 weeks.

Group Type: EXPERIMENTAL

ibuprofen

Intervention Type: DRUG

Ibuprofen tapering schedule during 3 weeks. First week: Ibuprofen 600 mg every 8 hours. Second week: Ibuprofen 600 mg every 12 hours. Third week: Ibuprofen 600 mg every 24 hours.

Acetaminophen

Acetaminophen or metamizole in case of allergy until pain resolution, according to routine clinical practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ibuprofen

Ibuprofen tapering schedule during 3 weeks. First week: Ibuprofen 600 mg every 8 hours. Second week: Ibuprofen 600 mg every 12 hours. Third week: Ibuprofen 600 mg every 24 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older.
• Patients hospitalized for confirmed acute myocarditis and left ventricular ejection fraction ventricular >50%.
• Elevated troponin I/T (3 times above the upper limit of normal).
• Absence of acute heart failure.
• Absence of ischemic heart disease (ruled out by coronary angiography or coronary CT in individuals over 40 years).
• Diagnostic criteria for myocarditis (Lake Louise, 2018 update) by cardiac magnetic resonance imaging.

Exclusion Criteria

• Kidney disease stage 3b, 4 and 5 (creatinine clearance by CKD-EPI <45 ml/min/1.73 m2).
• Severe liver failure (Child-Pugh class C).
• Poorly controlled pharmacological hypertension (repeatedly systolic arterial pressure >140 mmHg).
• Diagnosis criteria for acute pericarditis.
• Moderate or severe pericardial effusion (>10 mm in total).
• Hypersensitivity to NSAIDs or previous use in the last 7 days.
• Contraindication for MRI.
• Participation in another clinical trial.
• Pregnancy, breastfeeding, or women of childbearing age unwilling to use appropriate contraception throughout the study.
• Any circumstance that, in the investigator's opinion, compromises participation in the clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Investigación Biomédica Puerta de Hierro Majadahonda

UNKNOWN

Sponsor Role: collaborator

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Domínguez-Rodriguez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Failure and Inherited Cardiac Diseases Unit, Department of Cardiology, Hospital Universitario Puerta de Hierro, IDIPHISA, Madrid, Spain

Pablo García-Pavía, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Failure and Inherited Cardiac Diseases Unit, Department of Cardiology, Hospital Universitario Puerta de Hierro, IDIPHISA, Madrid, Spain

Locations

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, Spain

Countries

Spain

Other Identifiers

2024-513803-15-00

Identifier Type: CTIS

Identifier Source: secondary_id

2024-513803-15-00

Identifier Type: -

Identifier Source: org_study_id